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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05698602
Other study ID # Nivolis
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 24, 2023
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source VIVARDIS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

NivolisMonitor and NivolisAnton are new devices developed by Vivardis. NivolisMonitor is a generic and autonomous device for remote monitoring of ventilatory parameters generated by ventilatory assistance systems. NivolisMonitor uses its sensors to measure ventilation parameters such as pressure, flow, temperature and relative humidity, Fi02 provided by respiratory treatment devices (NIV, HDN (High Nasal Flow) and Oxygen therapy). NivolisMonitor records this data, stores it and transmits it to the healthcare professionals in charge of the patient. NivolisAnton is a medical device for telemonitoring of transcutaneous capnia, it thus helps to make recordings at the patient's home and to transmit data to healthcare professionals. The main objective of this study is to show that the use of NivolisMonitor and NivolisAnton is done in complete safety and that the clinical performances of these two devices are achieved. For this, the data measured by NivolisMonitor will be compared with the data provided by the treatment devices used by patients at home and the data provided by NivolisAnton will be compared with the data reported by the transcutaneous capnia monitor. The secondary objectives concern the evaluation of the acceptability/usability of the devices by patients and healthcare professionals. This evaluation will take the form of an observational clinical study on 10 patients, including : - a selection of patients already treated with NIV or HDN according to the inclusion/non-inclusion criteria and submission of the information note - an inclusion visit taking place during a routine pulmonological follow-up visit for these patients with collection of the free and informed consent of each patient. The blood gas data collected during this routine consultation will be compiled in the study observation book. - a 3-day monitoring period: - use over 3 days of the NivolisMonitor device at home, with on the last day the completion of the patient acceptability/usability questionnaire - overnight use of NivolisAnton - a teleconsultation to close the study for each patient - completion of the healthcare professional acceptability/usability questionnaire at the end of the study


Description:

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Study Design


Intervention

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Locations

Country Name City State
France CHU Grenoble Alpes Grenoble

Sponsors (1)

Lead Sponsor Collaborator
VIVARDIS

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ventilatory frequency expressed in breaths.min-1 The values of ventilatory frequency assessed by NivolisMonitor will be compared to ventilatory frequency values measured by Resmed NIV or Philipps NIV.
Ventilatory frequency is expressed as a median or average value, and compared according to the used NIV, respectively : Median for Resmed NIV and Average for VNI Philipps.
At the end of the 3-day monitoring period
Primary Leaks expressed in L.min-1 The values of Leaks assessed by NivolisMonitor will be compared to leaks values measured by Resmed NIV or Philipps NIV.
Leaks are expressed as a median or average value, and compared according to the used NIV, respectively : Median for Resmed NIV and Average for VNI Philipps.
At the end of the 3-day monitoring period
Primary Use of the device expressed in Hours The values of Use of the NIV device assessed by NivolisMonitor will be compared to Use of the device values measured by Resmed NIV or Philipps NIV.
Use of the device is expressed as a median or average value, and compared according to the used NIV, respectively : Median for Resmed NIV and Average for VNI Philipps.
At the end of the 3-day monitoring period
Primary Air Flow expressed in L.min-1 The values of Air Flow assessed by NivolisMonitor will be compared to Air Flow values prescribed for Resmed NIV or Philipps NIV or HDN devices.
Air Flow is expressed as a median value.
At the end of the 3-day monitoring period
Primary FiO2 expressed as percent NivolisMonitor measures FiO2 values of air delivered for Resmed NIV or Philipps NIV or HDN use.
FiO2 is expressed as a median value.
At the end of the 3-day monitoring period
Primary Temperature Expressed in degree Celsius NivolisMonitor measures Temperature values of air delivered for Resmed NIV or Philipps NIV or HDN use.
Temperature is expressed as a median value.
Median Temperature Expressed in degree Celsius
At the end of the 3-day monitoring period
Primary Relative Humidity expressed as percent RH NivolisMonitor measures relative humidity values of air delivered for Resmed NIV or Philipps NIV or HDN use.
Relative humidity is expressed as a median value.
At the end of the 3-day monitoring period
Primary Device Use expressed in Hours NivolisMonitor measures use of device values for Resmed NIV or Philipps NIV or HDN devices.
Use of device is expressed as a median value.
At the end of the 3-day monitoring period
Primary TcPCO2 values expressed in mm Hg NivolisAnton collects tcPCO2 values from Sentec SDM monitor. tcPCO2 value, collected by NivolisAnton, expressed in average during the overnight recording will be compared to tcPCO2 value measured by Sentec SDM monitor At the end of the 3-day monitoring period
Secondary Patient Usability of NivolisMonitor NivolisMonitor patient usability will be assessed with a usability questionnaire.
Usability questionnaire consits in 5 questions. For each question, 6 answers are proposed ranging from Totally Agree to Totally Disagree.
At the end of the 3-day monitoring period
Secondary Health Practitioner Usability of NivolisMonitor NivolisMonitor health practitioner usability will be assessed with a usability questionnaire Usability questionnaire consits in 10 questions. For each question, 3 answers are proposed ranging from Completely Disagree to Totally Agree. At the end of the 3-day monitoring period
Secondary Health Practitioner Usability of NivolisAnton NivolisAnton health practitioner usability will be assessed with a usability questionnaire Usability questionnaire consits in 10 questions. For each question, 3 answers are proposed ranging from Completely Disagree to Totally Agree. At the end of the 3-day monitoring period
Secondary tcPCO2 corrected values expressed in mm Hg NivolisAnton collects tcPCO2 values from Sentec SDM monitor. During a night of recording with Sentec SDM monitor, a drift appears in tcPCO2 values, this drift is corrected according to a corrector factor calculated by Sentec SDM monitor at the end of the recording.
tcPCO2 corrected value, measured by NivolisAnton, expressed in average during the overnight recording will be compared to tcPCO2 corrected value measured by Sentec SDM monitor
At the end of the 3-day monitoring period
Secondary SaO2 expressed in % NivolisAnton collects SaO2 values from Sentec SDM monitor. SaO2 value, collected by NivolisAnton, expressed in average during the overnight recording will be compared to SaO2 value measured by Sentec SDM monitor
NivolisAnton : Physiological data collected during registration:
Arterial saturation with O 2 (SaO2) in %
Heart Rate (HR) in Beats Per Minute
At the end of the 3-day monitoring period
Secondary Heart Rate (HR) in Beats Per Minute NivolisAnton collects Heart Rate values from Sentec SDM monitor. HR value, collected by NivolisAnton, expressed in average during the overnight recording will be compared to HR value measured by Sentec SDM monitor At the end of the 3-day monitoring period
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